Adherence to Dolutegravir and Outcome

Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02878642

Acronym

DOLUTECAPS

Enrollment

120

Registered

2016-08-25

Start date

2015-05-31

Completion date

2017-12-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Brief summary

The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance). While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HIV-1 * Age over 18 years * Information letter signed * ART (antiretroviral therapy) with at least 3 active molecules * Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure)

Exclusion criteria

* pregnant woman * HIV-2 * Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization) * Patient receiving aid incompatible with compliance with the use of electronic pillbox

Design outcomes

Primary

Measure	Time frame	Description
Adherence to dolutegravir measured by the electronic pill boxes	From baseline up to week 24	Calculating the total compliance
Virologic Efficacy	week 24	Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.

Secondary

Measure	Time frame
Patient Genotype resistance if failure	Week 16 and 24

Countries

France

Contacts

Primary ContactJean Jacques PARIENTI, MD,PhD

parienti-jj@chu-caen.fr02 31 06 43 20

Outcome results